DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s arguments filed in the reply on July 10, 2026 were received and fully considered. Claims 1 and 9 were amended. Claims 2-3 were cancelled. Please see below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/10/2026 has been entered.
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Such claim limitations is/are:
(Claim 6) “an automatic cannula insertion mechanism to propel the cannula bevel into the subject's skin.”
A review of the specification shows the following corresponding structure described in the specification for the above 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
(Claim 6) “an automatic cannula insertion mechanism to propel the cannula bevel into the subject's skin.”: As identified by the Specification, by incorporation of US 8,475,432, the following is recognized as the corresponding structure to the automatic cannula insertion mechanism: “The coil spring bias member 155 is configured to be in a compressed state, when the needle carriage 146 is in the retracted position (shown in FIG. 7), and an expanded state, when the needle carriage 146 is in the extended position (shown in FIG. 8). When in the compressed state shown in FIG. 7, the coil spring bias member 155 imparts a bias force on the needle carriage 146, in the direction of arrow 158. The needle carriage 146 may be held in the retracted position user (or other user) to selectively activate the needle inserter device by releasing the needle carriage and allowing the force of the bias member 155 to move the needle carriage 146 in the direction of the arrow 158. In the embodiment of FIG. 7, the actuation member 159 includes a rigid lever (or other structural member) that engages a stop surface 161 on the needle carriage 146 and is moveable in the direction of arrow 163 (by actuation of a manual lever, button or other operator, not shown) to a position in which the lever does not engage the stop surface 161, to allow the needle carriage 146 to move in the direction of arrow 158, under the force of the first bias member 155. While a manual lever, button or other operator may be employed to initiate movement of the actuation member 159, other embodiments may employ an automatic activation mechanism for moving the actuation member 159 (or otherwise release the needle carriage 146 for movement in the direction of arrow 158), such as, but not limited to, a mechanism that moves the actuation member 159 or otherwise releases the needle carriage for movement, in response to an expiration of a period of time from a sensor detecting the application of the delivery device (or components thereof) on the skin of user (or in another suitable location of operation).” Or equivalents thereof.
If applicant wishes to provide explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 9, the term “a detector including a only two electrical sensing elements located on or adjacent to the cannula for detecting when the cannula, catheter or probe has reached full penetration depth in the subject's skin;” should be replaced with --a detector including [[a]] only two electrical sensing elements located on or adjacent to the cannula, catheter, or probe for detecting when the cannula, catheter or probe has reached full penetration depth in the subject's skin;-- for grammatical clarity and consistency.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter et al (US 2009/0005665) (“Hayter”) as evidenced by Steil et al (US 2008/0183060) (“Steil”) in view of Grundmann (US 2008/0027475) and further in view of Paassilta et al (US 2010/0286507) (“Paassilta”).
Regarding Claim 1, while Hayter teaches a cannula insertion monitor (Abstract, [0075]-[0080], Figs. 7-9, 17), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 4A-4B, [0057]-[0060] insertion tip 430 penetrates through skin into subcutaneous space, indicating a sharpened tip at distal end with the housing at the proximal end);
a single electrically insulating layer on the cannula (Fig. 4B, [0061] “Additionally, within the scope of the present disclosure, some or all of the electrodes 401, 402, 403 may be provided on the same side of the substrate 404 in a stacked construction as described above, or alternatively, may be provided in a co-planar manner such that each electrode is disposed on the same plane on the substrate 404, however, with a dielectric material or insulation material disposed between the conducting layers/electrodes.” the stacked insulating layers of the figure may be substituted with a design of co-planar electrodes with an insulating material between the co-planar electrodes, indicating a single co-planar insulating layer);
an electrically conductive distal electrode, surrounded partially by the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode, surrounded by the insulating layer ([0057]-[0060] working electrode 401 as distal electrode, counter electrode 403 as proximal electrode, [0061] in a co-planar fashion would be radially outward on an insertion tip);
a housing adapted to be positioned against a subject's skin (Fig. 4B), the housing having a sensor circuit electrically connected with the distal electrode and the proximal electrode (Fig. 2, processor 204) and detecting an electrical property of the tissue between said distal electrode and proximal electrode (Figs. 4 and 7, [0082] the measured signal is ADC count, where it would be known in the art that the ADC count from the inserted electrodes is a detection of an electrical property of the tissue between said distal electrode and proximal electrode. Steil provides the requisite explanation in [0074]-[0075] where a similar three electrode system penetrates a subject and the working electrode WRK corresponds to Hayter’s proximal electrode and the counter electrode CNT corresponds to Hayter’s distal electrode. Here it is explained that a circuit is completed between these electrodes on the cannula tip when inserted into the subject’s interstitial fluid. A set voltage is applied and an analog current signal is generated between the working electrode and the counter electrode, in relation to the electrical property of the tissue {e.g. the impedance of the interstitial fluid}. Due to Ohm’s law, where voltage is the product of current and impedance, a set voltage would necessitate proportional changes occur in the impedance in relation to changes to the current. Thus, the analog signal of Hayter will have current as the value converted to a digital signal for counts and the changing current acts as an electrical property of the interstitial fluid between the electrodes when a voltage is set as constant. This explanation is further supported as the background for Hayter’s measuring as Hayter’s desired measuring environment is also the subject’s interstitial fluid);
wherein, when the cannula is fully inserted, the distal electrode and the proximal electrode are both within an interstitial space ([0057]), and a current in the sensor circuit flows between the distal electrode and the proximal electrode (Hayter [0082], Steil [0074]-[0075]);
an alert mechanism responsive to the change in electrical property providing indication of insertion status of the cannula ([0082]-[0087], [0133]-[0114] user notification provided in response to sensor condition, the sensor condition may indicate improper insertion status, and insertion status is found from ADC count of electrodes. Therefore, the ADC count, representing the change in electrical property of the interstitial fluid, will provide an indication of insertion status of the cannula).
Hayter fails to teach
wherein, when the subject's skin is tented around the cannula such that the cannula is not inserted fully, the proximal electrode does not enter the interstitial space, and conductivity between the distal electrode and the proximal electrode is affected in a predictable direction; and
wherein the sensor circuit detects the change in conductivity between electrodes to determine insertion status of the cannula.
However Grundmann teaches a puncturing device with insertion monitoring (Abstract) comprising
a puncturing element having a distal end with a sharpened tip and a proximal end (Fig. 1, [0023]-[0029] puncturing device 7 is shown with electrode 6 as part of a sharpened tip at a distal end, the puncturing device 7 further including a proximal end);
wherein, when the puncturing element is appropriately inserted, the distal electrode is in the interstitial space, and a current in the sensor circuit flows between the distal electrode and the proximal electrode ([0024] characteristic changes occur in electrode measurements based on what body fluid is being contacted, which can be used for appropriate insertion monitoring, the body fluid for a distal electrode can be interstitial fluid, [0025]-[0026] distal electrode is electrode 6 and proximal electrode is counter electrode 12. When at the appropriate penetration length, the proximal electrode is in the skin and the distal electrode is in the interstitial fluid. Examiner notes that Figure 1 implies a monitoring environment of interstitial fluid in capillary layer 3 as electrode 6 seems to be under the stratum corneum and above the capillaries loops);
wherein, when the subject's skin is tented around the puncturing element such that the puncturing element is not inserted appropriately, the proximal electrode does not enter the skin, and conductivity between the distal electrode and the proximal electrode is affected in a predictable direction ([0024]-[0029] should tenting occur at the skin, the skin surface around the puncturing element will be translated downwards and the proximal electrode 12 will not enter the skin as recreated below
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This scenario changes the expected conductivity characteristics between the electrodes in a measurable manner as recognized by [0024]); and
wherein the sensor circuit detects the change in conductivity between electrodes to determine insertion status of the cannula (Abstract, [0024], [0027]).
It would have been obvious to one of ordinary skill in the art at the time of the invention that the spaced electrodes used for insertion monitoring of Hayter can be distanced to utilize the conductivity characteristics of different layers of body composition to identify whether a desired insertion depth has occurred as taught by Grundmann as a way to provide greater sensitivity to Hayter’s insertion status identification. That is to say, to identify not only that the system is in an environment to collect data (Hayter’s ADC counts), but that the conductivity characteristics indicate that the electrodes are optimally placed in the environment (Grundmann’s conductivity analysis based on the desired penetration depth). Finally it would be obvious to tailor these tracked characteristics to Hayter’s ideal monitoring environment, where both electrodes are in the interstitial fluid. A manner to do this would be track when the proximal electrode in Hayter transitions from showing characteristics of skin conductivity to showing characteristics of being within interstitial fluid.
Yet their combined efforts fail to teach
the electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer.
However Paasilta teaches a cannula insertion monitor (Abstract, [0028] needle insertion monitoring may be broadly combined with “a syringe, catheter, sampling device or similar device structures comprising a needle to be inserted into the organ system”), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 1-2, [0028], [0030] needle 2 with a distal end with a sharpened tip / distal tip 3 and [0032]-[0033] a processing unit 5 may be integrated into a needle supporting structure as shown in Fig. 2, the processing unit 5 and the catheter/syringe/sampling device together make up the housing);
a single electrically insulating layer on the cannula (Fig. 5, [0083]-[0084] " When the material of the frame 15 is electrically conductive, it may be isolated from the electrodes 16, 18, 21, 22 by coating the frame 15 with a non-conductive coating and by arranging the electrodes on top of this, or, alternatively, with an electrode structure comprising an insulation material layer insulating the electrical parts of the electrode from the needle frame 15.” third needle embodiment utilizes a single non-conductive or insulating coating / layer);
The electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer (Fig. 5, [0084] distal electrode 16 and proximal electrodes 18, 21, and 22 disposed radially outward on the needle, where the electrodes are on top of a non-conductive material over the needle frame 15 or have an insulating material between the electrodes and needle frame 15, indicating the electrode could be understood as on top of an intermediate insulating material placed on the needle frame 15);
a housing adapted to be positioned against a subject's skin (Figs. 1-2, the housing has the ability to be positioned against a subject’s skin), the housing having a sensor circuit electrically connected with the distal electrode and the proximal electrode and detecting an electrical property of the tissue between said distal electrode and proximal electrode (Fig. 2, [0028], [0032], [0037], [0073] pairs of electrodes used for measurement and electrically connect to sensor circuit / microprocessor 26, detecting bioimpedance of tissue between electrodes);
an alert mechanism responsive to the change in electrical property providing indication of insertion status of the cannula ([0041]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the insulation layer construction of Paassilta to the insulation layer of Hayter as Paassilta provides a detailed layout on how co-planar electrodes can be placed on an insertion tip utilizing a single insulating layer, enabling a standardized construction for the co-planar version of the insertion tip detailed in Hayter.
Regarding Claim 4, Hayter, Steil, Grundmann, and Paassilta teach the cannula insertion monitor according to claim 1, wherein the change in electrical property is a change in current travelling between the proximal and distal electrodes (See Claim 1 Rejection).
Regarding Claim 5, Hayter, Steil, Grundmann, and Paassilta teach the cannula insertion monitor according to claim 1, wherein the electrically insulating layer is coated on the cannula, and the distal electrode and proximal electrode are coated on the electrically insulating layer (See Claim 1 Rejection, Paassilta [0080]-[0084] conductive material and insulative material may be applied by coatings).
Regarding Claim 6, Hayter, Steil, Grundmann, and Paassilta teach the cannula insertion monitor according to claim 1, and Grundmann teaches a system further comprising an automatic insertion mechanism ([0025] puncturing element drive 8) and Paassilta teach a system further comprising an automatic cannula insertion mechanism to propel at least a portion of the cannula into the subject's skin ([0012]-[0013], [0090], [0097]-[0101], [0103]-[0106] master station attachment for attaching the needle system to the subject, actuating the needle’s insertion, where the insertion may be automated).
It would have been obvious to one of ordinary skill in the art at the time of the invention for Hayter’s needle system to further include an automatic cannula insertion mechanism to propel at least a portion of the cannula into the subject's skin as taught by Grundmann and Paassilta for the cannula of Hayter as such an automated system “facilitates the injecting of the needle to the correct location and at a right angle to the skin or the mucosa. Also when the needle is injected into the tissue, needle movements assisted by a motor are significantly more precise than hand movements.” (Paassilta [0105]).
Regarding Claim 7, Hayter, Steil, Grundmann, and Paassilta teach the cannula insertion monitor according to claim 1, and Hayter teaches wherein the alert mechanism comprises a signal transmitted to a remote blood glucose monitor or a remote medication delivery source ([0077], [0085]-[0087] where a receiver unit acts as remote blood glucose monitoring in the monitoring network of Hayter as noted in [0055]).
Regarding Claim 8, Hayter, Steil, Grundmann, and Paassilta teach the cannula insertion monitor according to claim 1, wherein the alert mechanism consists of one or more selected from the group consisting of visible light, audible alarm, sensible vibration or a combination thereof, driven by the sensor circuit to provide separate indications when the cannula is properly inserted and when the cannula is not properly inserted (See Claim 1 Rejection, Hayter [0085] has a display alarm, [0062] alarm may be a “visual, audible or tactile cue” of successful needle placement or insufficient needle insertion and Paassilta [0041] display provides real-time feedback of penetration position).
Claim(s) 9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Paassilta and further in view of Grundmann and further in view of Paassilta and further in view of Goode, Jr. et al (US 2006/0258929) (“Goode”) as noted in Applicant IDS dated 12/20/2023.
Regarding Claim 9, while Hayter teaches an insertion monitor (Abstract, [0075]-[0080], Figs. 7-9, 17), comprising:
a housing adapted to be positioned adjacent an insertion site on a subject's skin (Fig. 4B, sensor 400’s housing with insertion tip 430 inserted into insertion site),
a cannula, catheter or probe having a distal end adapted for insertion into a subject's skin and a proximal end received in the housing (Figs. 4A-4B, [0057]-[0060] insertion tip 430 / cannula inserted through skin by a sharpened tip at distal end with the housing at the proximal end), the cannula, catheter, or probe having a single electrically insulating layer provided on the cannula, catheter, or probe (Fig. 4B, [0061] “Additionally, within the scope of the present disclosure, some or all of the electrodes 401, 402, 403 may be provided on the same side of the substrate 404 in a stacked construction as described above, or alternatively, may be provided in a co-planar manner such that each electrode is disposed on the same plane on the substrate 404, however, with a dielectric material or insulation material disposed between the conducting layers/electrodes.” the stacked insulating layers of the figure may be substituted with a design of co-planar electrodes with an insulating material between the co-planar electrodes, indicating a single co-planar insulating layer);
a detector including a pair of electrical sensing elements located on or adjacent to the cannula, catheter, or probe for detecting when the cannula, catheter or probe has reached a full penetration depth in the subject's skin ([0057]-[0060] working electrode 401 as distal electrode, counter electrode 403 as proximal electrode, [0082]-[0087], [0113]-[0114]); and
wherein the pair of electrical sensing elements comprise an electrically conducting distal electrode on the cannula, catheter, or probe disposed radially outward, surrounded partially by the insulating layer and an electrically conductive proximal electrode on the cannula, catheter, or probe, disposed radially outward, surrounded partially by the insulating layer ([0057]-[0060] working electrodes 401 as distal electrode, counter electrode 403 as proximal electrode, [0061] in a co-planar fashion would be radially outward on an insertion tip),
Hayter fails to teach the detector including only two electrical sensing elements located on or adjacent to the cannula for detecting when the cannula, catheter or probe has reached full penetration depth in the subject's skin;
Wherein the only two electrical sensing elements consist of an electrically conducting distal electrode on the cannula, catheter, or probe disposed and an electrically conductive proximal electrode positioned proximally of the distal electrode.
wherein the detector detects full penetration depth by detecting a current flowing between the electrically conducting distal electrode and the electrically conducting proximal electrode when the electrically conducting distal electrode and the electrically conducting proximal electrode are both within an interstitial space of the insertion site; and
wherein the detector detects insufficient full penetration depth when the subject's skin is tented around the cannula, catheter, or probe such that the cannula, catheter, or probe is not inserted fully and the electrically conducting proximal electrode does not enter the interstitial space, affecting conductivity between the electrically conducting distal electrode and the electrically conducting proximal electrode in a predictable direction.
However Grundmann teaches a puncturing device with insertion monitoring (Abstract) comprising
a puncturing element having a distal end adapted for insertion into a subject’s skin and a proximal end (Fig. 1, [0023]-[0029] puncturing device 7 is shown with electrode 6 as part of a sharpened tip at a distal end, the puncturing device 7 further including a proximal end);
a detector including only two electrical sensing elements located on or adjacent to the cannula, catheter, probe for detecting when the cannula, catheter or probe has reached appropriate penetration depth in the subject's skin ([0024] characteristic changes occur in electrode measurements based on what body fluid is being contacted, which can be used for appropriate insertion monitoring, the body fluid for a distal electrode can be interstitial fluid, [0025]-[0026] detector / electrical measuring facility 10 includes only two electrical sensing elements located on the penetrating element, electrode 6 and counter electrode 12. When at the appropriate penetration length, counter electrode 12 is in the skin and electrode 6 is in the interstitial fluid. Examiner notes that Figure 1 implies a monitoring environment of interstitial fluid in capillary layer 3 as electrode 6 seems to be under the stratum corneum and above the capillaries loops);
wherein the only two electrical sensing elements consist of an electrically conducting distal electrode on the cannula, catheter, or probe disposed radially outward on the penetrating element and an electrically conducting proximal electrode on the cannula, catheter, or probe disposed radially outward on the penetrating element (Fig. 1, [0024]-[0026] distal electrode / electrode 6 and proximal electrode / counter electrode 12);
wherein the detector detects appropriate penetration depth by detecting a current flowing between the electrically conducting distal electrode and the electrically conducting proximal electrode when the electrically conducting distal electrode is within the interstitial space of the insertion site and the electrically conducting proximal electrode is within the skin of the insertion ([0024] characteristic changes occur in electrode measurements based on what body fluid is being contacted, which can be used for appropriate insertion monitoring, the body fluid for a distal electrode can be interstitial fluid, [0025]-[0027]);
wherein the detector detects insufficient penetration depth when the subject's skin is tented around the cannula, catheter, or probe such that the cannula, catheter, or probe is not inserted fully and the electrically conducting proximal electrode does not enter the appropriate space, affecting conductivity between the electrically conducting distal electrode and the electrically conducting proximal electrode in a predictable direction ([0024]-[0029] should tenting occur at the skin, the skin surface around the puncturing element will be translated downwards and the proximal electrode 12 will not enter the skin as recreated below
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This scenario changes the expected conductivity characteristics between the electrodes in a measurable manner as recognized by [0024]); and
wherein the sensor circuit detects the change in conductivity between electrodes to determine insertion status of the cannula (Abstract, [0024], [0027]).
It would have been obvious to one of ordinary skill in the art at the time of the invention that the spaced electrodes used for insertion monitoring of Hayter can be distanced to utilize the conductivity characteristics of different layers of body composition to identify whether a desired insertion depth has occurred as taught by Grundmann as a way to provide greater sensitivity to Hayter’s insertion status identification. That is to say, to identify not only that the system is in an environment to collect data (Hayter’s ADC counts), but that the conductivity characteristics indicate that the electrodes are optimally placed in the environment (Grundmann’s conductivity analysis based on the desired penetration depth). Finally it would be obvious to tailor these tracked characteristics to Hayter’s ideal monitoring environment, where both electrodes are in the interstitial fluid. A manner to do this would be track when the proximal electrode in Hayter transitions from showing characteristics of skin conductivity to showing characteristics of being within interstitial fluid.
Yet their combined efforts fail to teach wherein the only two electrical sensing elements consist of an electrically conducting distal electrode on the cannula, catheter, or probe disposed on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed on the insulating layer.
However Paassilta teaches a cannula insertion monitor (Abstract, [0028] needle insertion monitoring may be broadly combined with “a syringe, catheter, sampling device or similar device structures comprising a needle to be inserted into the organ system”), comprising:
a cannula having a distal end with a sharpened tip and a proximal end positioned in a housing (Figs. 1-2, [0028], [0030] needle 2 with a distal end with a sharpened tip / distal tip 3 and [0032]-[0033] a processing unit 5 may be integrated into a needle supporting structure as shown in Fig. 2, the processing unit 5 and the catheter/syringe/sampling device together make up the housing);
a single electrically insulating layer on the cannula (Fig. 5, [0083]-[0084] " When the material of the frame 15 is electrically conductive, it may be isolated from the electrodes 16, 18, 21, 22 by coating the frame 15 with a non-conductive coating and by arranging the electrodes on top of this, or, alternatively, with an electrode structure comprising an insulation material layer insulating the electrical parts of the electrode from the needle frame 15.” third needle embodiment utilizes a single non-conductive or insulating coating / layer);
The electrically conductive distal electrode disposed radially outward on the insulating layer and an electrically conductive proximal electrode positioned proximally of the distal electrode disposed radially outward on the insulating layer (Fig. 5, [0084] distal electrode 16 and proximal electrodes 18, 21, and 22 disposed radially outward on the needle, where the electrodes are on top of a non-conductive material over the needle frame 15 or have an insulating material between the electrodes and needle frame 15, indicating the electrode could be understood as on top of an intermediate insulating material placed on the needle frame 15).
It would have been obvious to one of ordinary skill in the art at the time of the invention to apply the insulation layer construction of Paassilta to the insulation layer of Hayter as Paassilta provides a detailed layout on how co-planar electrodes can be placed on an insertion tip utilizing a single insulating layer, enabling a standardized construction for the co-planar version of the insertion tip detailed in Hayter.
Yet their combined efforts fail to teach the detector including only two electrical sensing elements located on or adjacent to the cannula for also detecting analyte levels of glucose.
However Goode teaches a glucose sensing system (Abstract) comprising a penetrating cannula for measuring an interstitial fluid with a reference electrode, counter electrode, and working electrode ([0153]-[0155], [0190]-[0194]) and further teaches that a single electrode can act as both a reference electrode and counter electrode ([0199]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the counter electrode and reference electrode of Hayter into a single electrode as taught by Goode as a way to simplify the system by reduce the amount of required components.
Regarding Claim 15, Hayter, Steil, Grundmann, Paassilta, and Goode teach the insertion monitor according to claim 9, wherein an electrical current flows between said electrodes when the cannula, catheter or probe has reached full penetration depth in the subject's skin (See Claim 9 Rejection, Grundmann: an electrical current flows between said electrodes when an appropriate penetration depth has been reached, Hayter, where an appropriate penetration depth is a full penetration depth with the housing against the patient’s skin).
Response to Arguments
Applicant's amendments and arguments, filed 7/10/2026, with respect to the 35 USC 103 rejections of Claim 1 have been fully considered, and are persuasive. The rejection is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hayter, Steil, Grundmann, and Paassilta.
Applicant's amendments and arguments, filed 7/10/2026, with respect to the 35 USC 103 rejections of Claim 9 have been fully considered, and are persuasive. The rejection is withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hayter, Steil, Grundmann, Paassilta, and Goode.
Claims 2-8 and 15 remain rejected due to their dependencies on rejected independent claims 1 and 9.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Henning et al (US 2012/0296187) (“Henning”) teaches an analyte sensor comprising controlled insertion depth comprising electrically conductive electrodes disposed radially outward on an insulating layer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights